Patients Treated in Four Additional Hospitals Using New Portable System
REDWOOD CITY, CA / ACCESSWIRE / March 7, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the expansion of first case experience with its new Lightbox 3 imaging console to four additional hospitals in Pennsylvania and New Jersey. Patients were treated at the four sites over three days using a single Lightbox 3 in a portable system configuration designed for easy transport and set-up by Avinger's clinical sales team. The portable system configuration includes the Lightbox 3 console in a lightweight, protective roller case similar in size to a carry-on suitcase and a collapsible stand that can be set-up in minutes with no tools required.
"As a long-time user of Avinger's image-guided catheters to treat my PAD patients, I am a strong proponent of the significant clinical benefits provided by real-time, intravascular OCT-imaging during treatment," commented Dr. Edward Pavillard, a vascular surgeon at Tower Health Medical Group. "I was impressed with the enhanced quality of the high-definition imaging provided by the Lightbox 3 and pleased with how efficiently we were able to perform the case. By visualizing the disease burden and arterial structures of the vessel wall during treatment, I was able to safely cross a 400 mm CTO with the Tigereye catheter followed by efficient debulking of the vessel with the Pantheris atherectomy device. I am looking forward to using Lightbox 3 in additional cases and excited about the progress Avinger is continuing to make in advancing this important technology."
The Lightbox 3 portable configuration opens new revenue model opportunities for Avinger and expands the opportunities for adoption of its best-in-class PAD therapeutic solutions at clinical sites.
"We are passionate about bringing the clinical benefits of our proprietary Lumivascular technology to an expanded number of physicians and their patients," remarked Phil Preuss, Avinger's Chief Marketing Officer. "In addition to the important clinical benefits provided by the Lightbox 3, we are confident the small size and portability of this new compact imaging console will expedite the evaluation process and accelerate our pace of new account acquisition. I was excited by how efficiently we could bring the Lightbox 3 into a clinical site and how quickly we could be prepared to support cases. Most of all, it was gratifying to see the positive clinical outcomes the talented physicians in these hospitals were able to deliver for their patients using Avinger's image-guided interventional devices."
The Lightbox 3 received 510(k) pre-marketing clearance from the U.S. Food & Drug Administration (FDA) in January. First cases in the U.S. were completed at two hospitals in Chicago and Arkansas during the week of February 21. Avinger is expanding availability of the Lightbox 3 to additional sites on a limited basis and anticipates progressing to full commercial availability early in the second quarter of 2022.
Lightbox 3 incorporates an advanced solid-state laser for high-definition intravascular OCT imaging, improving visualization while reducing the need for contrast dye, which can be contraindicated for many PAD patients. With a more powerful computing platform and redesigned software system, the highly intuitive user interface emphasizes efficiency and ease-of-use in the cath lab setting. The Lightbox 3 also brings a significant reduction in size, weight and cost compared to the predecessor console, which is anticipated to accelerate the evaluation process and reduce barriers to developing new accounts. The Lightbox 3 fits into a carry-on sized case and weighs less than 20 pounds - a 90% reduction in size and weight that provides for easy transport, efficient installation, and a simplified service strategy.
Avinger's proprietary Lumivascular technology allows physicians, for the first time ever, to see inside the artery during an atherectomy or CTO-crossing procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger's Lightbox console. Physicians performing atherectomy or crossing CTOs with other devices must rely solely on X-ray and tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, due to real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.
About Avinger, Inc.
Avinger is a commercial-stage medical device company that designs and develops the first and only image-guided, catheter-based system for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD). PAD is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot and Tigereye™ family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.
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Forward-Looking Statements
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the potential benefits of Lightbox 3 for patients and healthcare providers, the ease of introduction and use of Lightbox 3, our ability to generate new account acquisitions, the impact of Lightbox 3 on the adoption of our image-guided devices and other technology, the timing and scope of the commercial launch of Lightbox 3, and the impact of Lightbox 3 on our business. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include our dependency on a limited number of products; the resource requirements related to Pantheris, Tigereye and our Lightbox imaging console; the outcome of clinical trial results; the adoption of our products by healthcare providers; as well as the other risks described in the section entitled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 11, 2021 and in our Quarterly Reports on Form 10-Q. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Avinger disclaims any obligation to update these forward-looking statements.
Investor Contact:
Mark Weinswig
Chief Financial Officer
Avinger, Inc.
(650) 241-7916
[email protected]
Matt Kreps
Darrow Associates Investor Relations
(214) 597-8200
[email protected]
SOURCE: Avinger, Inc.